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The STOP-HPV Trial 3: Prompts Intervention (STOP-HPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599583
Recruitment Status : Suspended (Temporarily suspending due to the impact of COVID-19 on practices.)
First Posted : July 26, 2018
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
American Academy of Pediatrics
University of Pennsylvania
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Rochester
Information provided by (Responsible Party):
Peter G Szilagyi, MD MPH, University of California, Los Angeles

Brief Summary:
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of the addition of prompts (period 3) to performance feedback (period 2, continued through period 3) and training providers previously received on HPV vaccine communication (period 1) to reduce MOs and increase HPV vaccination rates.

Condition or disease Intervention/treatment Phase
Immunization Vaccination Behavioral: STOP-HPV prompts intervention Not Applicable

Detailed Description:

This intervention will incorporate prompts via electronic health record (EHR) (e.g. alerts in electronic charts indicating patient is due for vaccination) and study practice staff prompts (reminders from study staff that a patient is due for vaccination, e.g. placing Vaccine Information Statements (VISs) on desk) to study practitioners that encourage HPV vaccination at all visits. An initial learning module on practitioner prompts will highlight how study practices can consistently implement both EHR and staff HPV vaccination prompts at all visits. Throughout the intervention, text message mini-lessons will remind participants how to best use prompts via EHR and/or office staff to improve HPV vaccination rates. This trial focuses on study period 3 where study periods are as follows:

Period 1: Arm-1 intervention study practices receive communication skills training; Arm-2 comparison study practices provide standard of care. Period 2: Arm-1 intervention study practices add performance feedback, building upon their prior training in communication skills; Arm-2 comparison study practices continue delivering standard of care. Period 3: Arm-1 intervention study practices add prompts, building upon prior communication skills and performance feedback; Arm-2 comparison study practices continue with standard of care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT study design will test the impact of the prompts intervention to reduce missed opportunities and raise HPV vaccine rates.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 3. Comparison of Prompts (in the Presence of Communication Skills and Performance Feedback) and Standard of Care
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Intervention
Arm 1 will receive the STOP-HPV prompts intervention
Behavioral: STOP-HPV prompts intervention
This intervention will be the addition of the prompts intervention (in the presence of communication skills training and continued performance feedback).

No Intervention: Control
Arm 2 will receive standard of care



Primary Outcome Measures :
  1. Change in the rate of missed vaccination opportunities among all clinicians [ Time Frame: Monthly for Period 3 and also aggregated over the 6 -month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed. ]
    Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 3 among all clinicians, with a focus on the contrast between the end of periods 2 and period 3.

  2. Change in the rate of missed vaccination opportunities among consenting clinicians [ Time Frame: Monthly for Period 3 and also aggregated over the 6 -month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed. ]
    Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 3 among consenting clinicians, with a focus on the contrast between the end of period 2 and period 3.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Practice Inclusion Criteria:

  • The practice provides HPV vaccination services to adolescents.
  • The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
  • The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
  • The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

  • The practice plans to change EHR systems in the next three years.
  • The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
  • Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599583


Locations
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United States, Illinois
American Academy of Pediatrics
Itasca, Illinois, United States, 60143
Sponsors and Collaborators
University of California, Los Angeles
Children's Hospital of Philadelphia
American Academy of Pediatrics
University of Pennsylvania
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Rochester
Investigators
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Principal Investigator: Peter Szilagyi, MD University of California, Los Angeles
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Responsible Party: Peter G Szilagyi, MD MPH, Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03599583    
Other Study ID Numbers: 3R01CA202261 ( U.S. NIH Grant/Contract )
R01CA202261 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter G Szilagyi, MD MPH, University of California, Los Angeles:
HPV
Vaccination
Practice based intervention